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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: winners18 who wrote (36024)	6/17/2016 11:27:50 PM
From: gary123	Read Replies (2) \| Respond to of 63324

This is what i suspected, with RR, we will know much earlier, in the first cycle. Now the reasons for Immu silence, may be the FDA is studying their proposals and did not make a decision, in this sense mgmt can't comment prematurely. I am not too familiar with the simon stage 2 analysis, but I am assuming if the second cohort of patients mirrors the first set(in the first few months) then "that it". I do expect a press release when the FDA announce their decision.

To: winners18 who wrote (36024)	6/18/2016 9:59:10 AM
From: weatherproof	1 Recommendation Recommended By Fitzhughlaw Read Replies (1) \| Respond to of 63324

Thanks for the reply, winners, but I was asking what you saw that led you to the conclusion in your earlier post which stated, "AA is based on RR!" I had initially heard it was PFS. In the cc, G makes it evident that OS will be critical in any consideration for AA. So, I'm asking you if you can support your exclamatory statement with something more than a comment by a Wells Fargo analyst. If not, that's fine. I was just curious where you came across your information. My own feeling is that there is concern as to whether or not there exists a positive correlation between the surrogate, PFS, and OS. As they commence with enrolling additional patients in stage 2 of the ph2, OS data continues to mature. I am thinking that individual patient outcomes will be looked at for the purpose of further examining that correlation. I know we have an SPA for the ph III, but consider this item taken from a FDA guidance document: "A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act)." It is also important that a prospective partner has confidence in the use of a surrogate endpoint. Would you want to invest maybe hundreds of millions of dollars on a ph II result, only to find out that the confirmatory trial doesn't show that there is a correlation between PFS and OS? So there may be some pressure there from a prospective partner. Consider this, also taken from an FDA guidance document: "When it is possible to use a later effect in a trial to verify the effect seen earlier in the same trial that supported accelerated approval, the same clinical trial(s) can be used to support accelerated approval and verify and describe the clinical benefit. In this case, the protocol and the statistical analysis plan should clearly account for an analysis of the surrogate endpoint data to provide support for accelerated approval, with continuation of the randomized trial(s) to obtain data on the clinical endpoint that will be the basis for verifying the clinical benefit. When the same trial is used to support accelerated approval and verify clinical benefit, the data to verify the clinical benefit may be, in some cases, nearly complete by the time of accelerated approval." I may be reading this wrong, but it seems to suggest that IMMU can file for AA as the OS data continues to come in from the ph2, acting, itself, as the confirmatory trial. Could this potentially preclude the need for a ph3?